The Division of Geriatrics and Clinical Gerontology (DGCG) at the National Institute on Aging (NIA) supports clinical trials on topics relating to aging and the elderly. Researchers with interest in trials whose direct costs are less than $2 million per year are encouraged to contact the Clinical Trials Branch staff at gcgquery@mail.nih.gov. DGCG also invites suggestions from the scientific community regarding needs for large (over $2 million direct costs per year) clinical trials in topic areas relevant to DGCG’s mission. NIA will use your suggestions in its planning process to select high priority topic areas in which significant existing knowledge indicates the need for large clinical trials to provide more definitive information on risks and benefits of interventions for diseases and conditions in the elderly.

Background

The DGCG supports research on health and disease in the aged as well as research on aging over the human life span including its relationships to health outcomes. DGCG comprises three major research areas: Geriatrics, Clinical Gerontology, and Clinical Trials. The Geriatrics Branch primarily focuses on health issues regarding the aged. The Clinical Gerontology Branch focuses on clinically-related issues regarding aging changes over the life span. The Clinical Trials Branch plans and administers clinical trials on age-related issues with emphasis on:

Interventions to prevent or treat “geriatric syndromes”, disability, and complications of comorbidity or polypharmacy

Trials to detect age- or comorbidity-related differences in responses to interventions against conditions found in middle age and old age

Interventions for problems associated with menopause and other mid- and late-life changes

Interventions that may affect rates of progression of age-related declines in function in early and midlife

Your suggestions will assist the DGCG in planning for large scale clinical trials in topic areas relevant to its mission where existing evidence suggests the need for definitive information about the benefits and risks of interventions for diseases and conditions in the elderly.

In contributing suggestions for areas where large clinical trials are needed, attention to the following elements will help in NIA’s planning process:

1. Provide a brief description of the topic area and current state of science indicating the need for a large scale clinical trial or trials to obtain definitive information about the benefits and / or risks of intervention or interventions in elderly in the topic area.

2. Define the prospective study population and briefly discuss a potential intervention or interventions and any preliminary information supporting the need for testing such an intervention or interventions in a large scale trial in the proposed population. Drugs, devices, lifestyle modifications, and other interventions could be proposed.

3. Provide a brief rationale for the selection of endpoints (clinical, functional, or surrogate). There is no need to propose specific outcome measures.

4. Provide an estimate of sample size, duration and costs of trial(s).

5. Provide any additional comments or suggestions that you think would be useful.

Inquiries

Please respond no later than September 1, 2009. We look forward to your suggestions and hope you will share this document with your colleagues.

To respond, please send your suggestions by a letter, fax, or email to the following address: